Beckman Coulter, Inc.: DxI 9000 Access Immunoassay Analyzer, Part Number C11137

Hazard

Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.

Details from the source

Reason for recall: Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected. Distribution: Worldwide - US Nationwide distribution. Quantity: 571 units Lot/code info: C11137 UDI-DI: 15099590732103; Serial Numbers: 300621 300655 300564 300572 300411 300425 300576 300577 300625 300295 300713 300714 300289 300497 300333 300520 300524 300440 300443 300441 300444 300445 300528 300515 300332 300466 300484 300412 300395 300541 300255 300270 300499 300435 300436 300467 300532 300560 300600 300604 300605 300607 300609 300610 300707 300709 300710 300596 300597 300374 300679 300677 300558 300559 300593 300584 300169 300239 300124 300225 300595 300638 300495 300496 300381 300668 300237 300156 300571 300641 300131 300637 300488 300142 300141 300143 300151 300152 300316 300546 300298 300299 300328 300414 300413 300422 300132 300534 300317 300318 300567 300568 300163 300162 300276 300277 300174 300226 300370 300459 300386 300503 300388 300389 300745 300742 300204 300216 300247 300246 300438 300149 300662 300716 300268 300380 300391 300429 300437 300303 300305 300349 300353 300290 300301 300243 300220 300166 300176 300188 300269 300273 300144 300398 300229 300721 300722 300199 300200 300309 300632 300602 300601 300314 300177 300224 300669 300628 300291 300223 300456 300719 300718 300410 300547 300450 300649 300116 300171 300368 300145 300250 300288 300331 300338 300362 300407 300670 300693 300190 300230 300235 300297 300203 300465 300241 300280 300684 300686 300493 300324 300570 300569 300592 300657 300285 300358 300457 300460 300249 300533 300680 300681 300682 300462 300373 300729 300665 300148 300153 300154 300158 300178 300267 300591 300616 300406 3004

UPC codes

15099590732103

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.